Mini Plus surgical kits recalled as not suitable for organ transplant
AVID Medical is recalling 380 Halyard Mini Plus Kit South units because the devices are not suitable for organ transplant. The FDA has classified the action as Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
The Halyard MINI PLUS KIT SOUTH, kit code JACK097-08, is being recalled by AVID Medical, Inc.
The reason given in the enforcement record is that the devices are not suitable for organ transplant.
The record lists 380 units carrying UDI 10809160462829, from lot 1654185. Distribution was nationwide in the United States, in Florida, Georgia and Puerto Rico. The FDA has classified the action as Class I, its most serious category.
Facilities should quarantine the affected lot immediately and follow the firm's instructions.
The recalled product
- Product
- Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Procedure tray
- Affected units
- 380
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Kit Code: JACK097-08
- UDI : 10809160462829
- Lot No: 1654185.
Distribution
Part of a larger recall action
This product is one of 3 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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